July 10, 2009
Our STN: BL 125163/125
Attention: Mary Beth Ebert, M.S.
2301 Renaissance Boulevard
Building 510, P.O. Box 61540
King of Prussia, PA 19406-2772
Dear Ms. Ebert:
We have approved your request to supplement your biologics license application for Influenza Virus Vaccine, FluLaval®, to include the 2009-2010 United States formulation.
Please submit final printed labeling at the time of use and include completed implementation information on FDA form 356h. Please provide PDF-format electronic copies of these labels.
We will include information contained in the above-referenced supplement in your biologics license application file.
Jerry P. Weir, Ph.D.
Division of Viral Products
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
Attachment: Approved final draft labeling